A clinical issue that has been concerning medical facilities for many years is how best to obtain a sterile urine, semen, soft stool, menses blood or other excrement biological sample, of bodily fluid from a patient. There is no American Medical Association standard policy or protocol for conducting bodily fluids sample collection.
Typically, the patient at a medical office is handed a urine sample cup and told to go into a restroom and urinate, filling that urine sample cup while it is being held in the patient's hand. A urine sample, in particular, is required to be free of bacteria which may collect around the exit to the bladder, in urinary passages, or exist on the patient's hands. In order to eliminate infecting the sample with the bacteria from the bladder or urinary passages, a mid-stream sample is requested to be collected, excluding the first part of a urine stream from the sample. The patient, therefore, must commence urinating before collecting the sample. Collecting a mid-stream sample may be difficult for many people.
Doctors, clinics, clinicians, nurses, parents, lab technician, other medical practitioners or caregivers, hospitals, prisons, senior centers, military facilities, rehab centers, disabled adult homes, and other employment testing situations (collectively, plural, “medical service provider”), potentially all need, at some time, to collect sterile urine samples. It is nearly impossible to maintain a sterile field or environment when the patient is holding the sample cup in their hand. There is no known technology being used to solve the problem of a patient maintaining a sterile field for a “clean catch”, particularly for women patients.
Patients having special needs; such as the elderly, obese or disabled, children, or pregnant women; have problems collecting such samples in the manner typically utilized. There is almost no way to do this without having the patient, the user, contaminating the sample cup and/or the actual bodily fluids sample. The device must be freely maneuverable, and able to easily receive and release sample receptacles, to be convenient for both the medical service provider and the patient.
While there are devices in the related art which can be mounted within a toilet bowl, utilizing the toilet bowl or seat as support, and have a receptacle for receiving a sample, there has been a need for such device that is freely maneuverable and usable with variously sized, commonly used receptacles. Devices which require installation within the toilet bowl, between the bowl and the toilet seat are not so maneuverable, awkward to use and to retrieve the sample receptacle, with the potential of losing or contaminating the sample.
Urine sample collection devices are known which have multiple parts, complicating their use and placement on or within a toilet, and utilize sample receptacles which are not the standard, plastic, disposable and sterile urine sample cups routinely used in medical offices, clinics and other locations where urine samples are frequently taken, requiring numerous receptacles. Some devices may provide for a standard sample cup or jar, but collect the sample in a reused collection section prior to collection in a jar. Even if reusable, these additional collection elements cause more waste material for disposal. As well, those devices may require the use of the toilet bowl as a support structure, causing the medical service provider or the patient to handle the toilet seat for installation and/or removal of the device. This known art does not provide for a sanitary sample collection procedure.
The bodily fluids collection devices described in the related art do not disclose features of the present invention and would not be as suitable for the required purpose of the present invention hereinafter described. Urine collection devices are well known in the related art, exemplified by U.S. Pat. No. 7,011,634 to Paasch et al (“Paasch”); U.S. Pat. Nos. 8,079,562 and 8,297,577, both to Denman (collectively, “Denman”); U.S. Pat. No. 6,811,754 to House (“House”); U.S. Pat. No. D489,453 to Sapyta (“Sapyta”)’ U.S. Pat. No. 42,032,169 to Dale (“Dale”); and U.S. Pat. No. 2,603,795 to Terlizzi (“Terlizzi”). Terlizzi does not disclose a removable urine sample cup, and neither Terlizzi, nor Dale teaches the use of a standard, plastic urine sample cup, for sample cups commonly used in the industry. Paasch and House disclose the use of additional sample collection trays along with a sample cup. None of the known devices except for House, disclose collecting the bodily fluids sample directly into a standard bodily fluids sample cup or jar. Dale, as well, is not mobile. Dale, House, Paasch, Sapyta and Denman all require use on a toilet bowl, and not the toilet seat. The present invention discloses a frame member planar from end to end, and not set within the toilet bowl. Dale, House, Paasch, Denman, and Sapyta all disclose devices that are not planar from end to end, but are set within the toilet bowl. None of the known devices disclose all the feature of the present invention where the sides of the elastic elongated frame member are angled inwardly, to facilitate engaging the bodily fluids sample cup.
None of the references contain every feature of the present invention, and none of these references in combination disclose or teach every feature of the present invention.
The foregoing and other objectives, advantages, aspects, and features of the present invention will be more fully understood and appreciated by those skilled in the art upon consideration of the detailed description of a preferred embodiment, presented below in conjunction with the accompanying drawings.